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Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial.

Publication ,  Journal Article
Derman, RJ; Kodkany, BS; Goudar, SS; Geller, SE; Naik, VA; Bellad, MB; Patted, SS; Patel, A; Edlavitch, SA; Hartwell, T; Chakraborty, H; Moss, N
Published in: Lancet
October 7, 2006

BACKGROUND: Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist--such as the uterotonic drug oxytocin--most are not feasible in resource-poor settings where many births occur at home. We aimed to investigate whether oral misoprostol, a potential alternative to oxytocin, could prevent postpartum haemorrhage in a community home-birth setting. METHODS: In a placebo-controlled trial undertaken between September, 2002, and December, 2005, 1620 women in rural India were randomised to receive oral misoprostol (n=812) or placebo (n=808) after delivery. 25 auxiliary nurse midwives undertook the deliveries, administered the study drug, and measured blood loss. The primary outcome was the incidence of acute postpartum haemorrhage (defined as > or =500 mL bleeding) within 2 h of delivery. Analysis was by intention-to-treat. The trial was registered with the US clinical trials database (http://www. clinicaltrials.gov) as number NCT00097123. FINDINGS: Oral misoprostol was associated with a significant reduction in the rate of acute postpartum haemorrhage (12.0% to 6.4%, p<0.0001; relative risk 0.53 [95% CI 0.39-0.74]) and acute severe postpartum haemorrhage (1.2% to 0.2%, p<0.0001; 0.20 [0.04-0.91]. One case of postpartum haemorrhage was prevented for every 18 women treated. Misoprostol was also associated with a decrease in mean postpartum blood loss (262.3 mL to 214.3 mL, p<0.0001). Postpartum haemorrhage rates fell over time in both groups but remained significantly higher in the placebo group. Women taking misoprostol had a higher rate of transitory symptoms of chills and fever than the control. INTERPRETATION: Oral misoprostol was associated with significant decreases in the rate of acute postpartum haemorrhage and mean blood loss. The drug's low cost, ease of administration, stability, and a positive safety profile make it a good option in resource-poor settings.

Duke Scholars

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Published In

Lancet

DOI

EISSN

1474-547X

Publication Date

October 7, 2006

Volume

368

Issue

9543

Start / End Page

1248 / 1253

Location

England

Related Subject Headings

  • Rural Health
  • Poverty Areas
  • Postpartum Hemorrhage
  • Oxytocics
  • Misoprostol
  • Midwifery
  • India
  • Humans
  • Home Childbirth
  • General & Internal Medicine
 

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Derman, R. J., Kodkany, B. S., Goudar, S. S., Geller, S. E., Naik, V. A., Bellad, M. B., … Moss, N. (2006). Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial. Lancet, 368(9543), 1248–1253. https://doi.org/10.1016/S0140-6736(06)69522-6
Derman, Richard J., Bhalchandra S. Kodkany, Shivaprasad S. Goudar, Stacie E. Geller, Vijaya A. Naik, M. B. Bellad, Shobhana S. Patted, et al. “Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial.Lancet 368, no. 9543 (October 7, 2006): 1248–53. https://doi.org/10.1016/S0140-6736(06)69522-6.
Derman RJ, Kodkany BS, Goudar SS, Geller SE, Naik VA, Bellad MB, et al. Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial. Lancet. 2006 Oct 7;368(9543):1248–53.
Derman, Richard J., et al. “Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial.Lancet, vol. 368, no. 9543, Oct. 2006, pp. 1248–53. Pubmed, doi:10.1016/S0140-6736(06)69522-6.
Derman RJ, Kodkany BS, Goudar SS, Geller SE, Naik VA, Bellad MB, Patted SS, Patel A, Edlavitch SA, Hartwell T, Chakraborty H, Moss N. Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial. Lancet. 2006 Oct 7;368(9543):1248–1253.
Journal cover image

Published In

Lancet

DOI

EISSN

1474-547X

Publication Date

October 7, 2006

Volume

368

Issue

9543

Start / End Page

1248 / 1253

Location

England

Related Subject Headings

  • Rural Health
  • Poverty Areas
  • Postpartum Hemorrhage
  • Oxytocics
  • Misoprostol
  • Midwifery
  • India
  • Humans
  • Home Childbirth
  • General & Internal Medicine